As is well known, since the crackdown on “aesthetic medical beauty masks” by the government, the promotion of medical device products as cosmetics has been severely punished for violating regulations. However, based on the latest penalty cases, there are still companies operating in a gray area of illegal claims.
Recently, according to an administrative penalty decision published by the Yunnan Provincial Medical Products Administration, Yunnan Kejing Biotechnology Co., Ltd. was fined due to misleading labeling of their gel dressings. What exactly happened in this case?
Misleading content on the label, resulting in a fine!
According to the penalty information released by the Yunnan Provincial Medical Products Administration, the product in question is gel dressings produced by Yunnan Kejing Biotechnology Co., Ltd. The registered scope of application for this product is “to cover non-infectious and superficial wounds, providing a moist environment for the wound, not suitable for chronic wounds.”
However, Yunnan Kejing Biotechnology labeled the product as “Biweiqing Light Wrinkle Eye Essence TM” on the product manual and label. Regulatory authorities believe that this labeling could mislead consumers into using the gel dressing as an eye essence for reducing wrinkles. Therefore, this violation is classified as “medical device with misleading content on the production manual and label,” and Yunnan Kejing Biotechnology was fined 10,000 yuan according to Article 88 of the Regulations on the Supervision and Administration of Medical Devices.
Through social media platforms, CHAILEEDO found that there are still many marketing promotions related to the “Biweiqing” product. Some of these products openly claim to be “eye firming essence,” “reducing fine lines,” and “solving all eye skin problems with one product,” while the product packaging indicates “gel dressings.”
According to public information on the official website of the National Medical Products Administration, Yunnan Kejing Biotechnology has registered a total of 10 medical device products, and the gel dressings are classified as Class II medical devices. They are amorphous gel dressings composed mainly of gel-forming substances (glycerin, carbomer, polyvinyl alcohol, triethanolamine) and purified water. The components are not absorbed by the human body. Sterile.
In other words, the product’s ingredients only include basic moisturizers, film formers, thickeners, etc., and its scope of application does not involve the efficacy of “reducing wrinkles,” as mentioned in its label. This undoubtedly contradicts the claims of “light wrinkle eye essence” mentioned on the label.
It is worth noting that according to public information from the China Trademark Office, Yunnan Kejing Biotechnology applied for dozens of Class 10 medical device trademarks in 2023, including “Biweiqing Light Wrinkle Eye Essence.” Many of these trademark names are related to common cosmetics, such as “XXX Moisturizing Water,” “XXX Nourishing Body Lotion,” “XXX Soothing and Moisturizing Repair Lotion,” “XXX Collagen Rejuvenating Anti-Aging Water,” etc. As of now, the trademark application processes are still ongoing.
“This is a typical case of pushing the boundaries.”
Regarding the penalty case, an industry insider who wished to remain anonymous told CHAILEEDO, “This is a typical case of pushing the boundaries, where the company adds a common cosmetic name to their existing trademark and registers a new trademark. The company was fined because ‘light wrinkle eye essence has nothing to do with dressings.’ ” Liu Qi, the General Manager of Shenzhen Yinnuosi Biopharmaceutical Co., Ltd., stated, “Essence falls under the category of cosmetics, and reducing wrinkles is also within the domain of cosmetic effects. Medical device product names have strict requirements, and using cosmetic names can indeed mislead consumers.”
In reality, compared to cosmetics, the naming of medical devices is more stringent and standardized. According to the “Naming Rules for Generic Names of Medical Devices” issued by the National Medical Products Administration, generic names of medical devices must not contain promotional words such as “beauty” or “healthcare,” as well as personal names, company names, registered trademarks, or similar names.
Wu Yongyao, the founder of Guangdong Yayue Biotechnology Co., Ltd., told CHAILEEDO that the naming and regulations for medical devices are very clear, and many cosmetic names and effects cannot be used in the naming of medical device products. “Medical device naming has its own specific expressions for product effects, and terms like physical penetration cannot be used. The product name is also fixed and cannot be changed.”
In other words, according to relevant regulations, the generic name of the product in the aforementioned penalty case can only be strictly named “gel dressings.” It may be due to the inability to change the generic name that some unscrupulous companies choose to exploit loopholes in regulations and promote medical device products as cosmetics through trademarks and other means.
CHAILEEDO’s search on platforms such as Douyin (Chinese version of TikTok) revealed a plethora of similar violations as in the aforementioned penalty case. For example, some products labeled as cooling gel dressings openly claim to “improve eye bags” or “reduce dark circles.”
“Medical devices and cosmetics are different types of products with completely different usage scenarios and purposes. In response to this behavior, regulatory authorities not only need to increase enforcement efforts but also need to further clarify the boundaries between them from a policy perspective. Only then can we reduce the existence of such chaos,” said a senior expert in cosmetic regulations.
Policy-level measures effectively regulate and rectify the market
In fact, in recent years, relevant departments have been continuously clarifying the boundaries between medical devices and cosmetics. In 2023 alone, the China National Institutes for Food and Drug Control (referred to as “CNIFDC”) announced the classification results of three batches of medical device products, further delineating the boundaries between cosmetics and medical dressings.
In this regard, CHAILEEDO has selected some medical device product classifications related to medical aesthetics and skincare and found that some dressing products have been excluded from the category of medical devices based on the defined claims of their effects. At the same time, some products with moisturizing and improving dermatitis and eczema effects are not regulated as medical devices.
For example, recombinant collagen protein liquid film dressings, which claim to moisturize and lock in water, relieve skin allergy symptoms, improve dermatitis, eczema, and certain skin problems caused by facial acne, and prevent pigmentation, are suggested by the CNIFDC not to be regulated as medical devices. Similar products include sodium hyaluronate patches and sodium hyaluronate gels.
It is also worth mentioning that in August of last year, the CNIFDC published the “Guiding Principles for Classification of Medical Dressing Products (Draft for Solicitation of Comments)” and explicitly stated that the management attribute of medical dressing products should be comprehensively determined based on the intended use and mechanism of action of the product. Products that do not meet the definition of medical devices specified in the “Regulations on the Supervision and Administration of Medical Devices” will not be regulated as medical devices.
At that time, industry insiders expressed to CHAILEEDO that scientifically defining medical dressings and restoring the essence of cosmetics, disinfection products, and drugs will effectively combat the long-standing chaos in the industry.
Among them, the first article of the “Guiding Principles” clearly states that “products applied to the skin, hair, nails, lips, and other human body surfaces by rubbing, spraying, or similar methods, for the purpose of cleaning, protecting, modifying, and beautifying,” which is also the basic definition of cosmetics. In addition, products that claim to relieve skin discomfort by providing moisturization, hydration, or reduce pigmentation, among other categories, do not meet the definition of medical devices.
The above definitions undoubtedly provide strong regulatory guidelines for the claims of most medical dressing products on the market, and they also provide a clear and scientific explanation for the boundary issues in the previous penalty case. At the same time, as regulatory authorities continue to strengthen their crackdown on such issues, they will effectively curb the long-standing illegal practice of marketing medical dressings as cosmetics from its root cause.
